ISO 23033:2021

Biotechnology — Analytical methods — General requirements and considerations for the testing and characterization of cellular therapeutic products

Publication date: Aug 27, 2021

General information

Current stage: 60.60 Effective date: Aug 27, 2021

Originator: ISO

Owner: ISO/TC 276

Type: International Standard

ICS: 07.080

Languages: English French

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Status: Published

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Scope

This document provides general requirements for the testing of cellular therapeutic products intended for human use.
This document also provides considerations for the characterization of cellular therapeutic products, including approaches to select and design analytical methods that are fit for purpose.
Such considerations can be used to establish critical quality attributes for a cellular therapeutic product.
This document is applicable to cellular starting materials (including those for tissue engineered products) and intermediates of cellular therapeutic products.
This document is not applicable to tissues used in transplantation.

Life cycle

NOW

PUBLISHED
ISO 23033:2021
60.60 Standard published
Aug 27, 2021

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